UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM

All software versions pior to version 1.4

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide and Canada

UniCel Dxl 800 Access Immunoassay System, P/N 973100.

Part Numbers: 386162 (software) 973100 (Instrument),  Software Versions 2.2.1 and earlier.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide and Canada

UniCel Dxl 800 Access Immunoassay System Software Versions 2.2.1 and earlier

In-vitro diagnostics

Serial Numbers: 600000 through 602389

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - USA (nationwide) and Internationally to Canada, AE, AU, BG, BW, CH, CN, CZ, DE, ES, FR, GB, HK, HR, HU, IN, IT, JO, JP, LB, MA, MX, NL, PL, QA, RO, RU, SK, TN, TR, ZA, AO, AR, AT, BE, CO, DZ, FI, IE, IL, KR, KW, LI, NA, NO, NZ, PF, PH, PR, SE, SG, SZ, TH, TW, VE, VN, and YT.

UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457. || The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer.

Peristaltic Pumps with Serial Numbers of 22454201 and above

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide, and in Canada

UniCel Dxl 800 Access Immunoassay System and UniCel DxC 880i Synchron Access Clinical System